The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) Initiative aims to develop a U.S. national device surveillance network in the vascular device space. VISION is a collaborative effort between the FDA’s MDEpiNet-Weill Cornell Medicine Science and Infrastructure Center, and vascular registries such as the Vascular Quality Initiative and the NYC Coordinated Data Registry Network.
The FDA’s new post-market surveillance vision highlights the importance of national registries and linkages with detailed datasets such as billing or administrative claims data and other routinely collected electronic data for the creation of a national system for post-market surveillance. Vascular implants are of particular importance, as vascular disease is a common, progressively debilitating disease with a high prevalence in older Americans, and vascular devices are used in millions of Americans annually.
Major evidence gaps in device performance exist and, through this project, we will capitalize on a novel partnership within the FDA’s Medical Device Epidemiology Network (MDEpiNet) to build a national infrastructure and fill the gaps in evidence. Our initiative aims to bring together registries in a systematic way and obtain longer, more complete patient follow-up via data linkages. Our network will be a resource to address the safety and effectiveness of new devices as they enter routine usage. Using this data network, researchers will be able to conduct comparative effectiveness studies within a short period after their market entry. Linkages between registries and state/national claims datasets will also significantly benefit registry efforts, including validation of complications, increased follow-up rate, ability for risk adjustment, and increased information about patient characteristics. This in turn will allow the registries to better serve their contributing hospitals by providing more detailed, useful reports.
By harmonizing and linking clinical registry information from diverse registries in the vascular setting, we aim to share knowledge about best practices for data collection, linkages with claims and other data systems, analytics, and dissemination. Moreover, the collaboration and demonstration of the value of registries will strengthen support from stakeholders. The consortium can serve as a basis for fulfillment of pre and post-approval requirements related to vascular devices.
The Vascular Quality Initiative (VQI) is a national data registry and quality improvement vehicle for the nation’s largest group of physicians that provide vascular care – the Society for Vascular Surgery (SVS). Since 2002, the VQI has collected data from its members – currently more than 400 hospitals and practices in 46 states and Canada – for outcomes analysis, benchmarking, and quality improvement. These data include more than 120 descriptive variables describing the patient’s vascular conditions, the precise details of the operative procedure and devices utilized during the procedure, as well as detailed peri-operative and long-term outcomes. The registry has on-line data collection mechanisms from site of care; is maintained by the SVS Patient Safety Organization (PSO); and is a certified PSO. Systematic claims and clinical audits ensure data completeness and 100% capture of all procedure-specific entries at each of the participating sites. Drs. Phil Goodney and Jack Cronenwett serve as leaders within VQI and principal co-investigators of the grant. They are seasoned researchers with tremendous expertise in vascular outcomes and device research.
The Department of Healthcare Policy and Research at Weill Cornell Medicine (WCM) is home to MDEpiNet’s Science and Infrastructure Center. It was previously a home to Agency for Healthcare Research and Quality (AHRQ)-funded Center for Education and Research on Therapeutics (CERT) focused on medical devices. WCMC and the partners in this effort provide a robust platform for large-scale research and surveillance efforts. Dr. Sedrakyan, the principal investigator, has extensive experience in medical device research and supervision. He worked at AHRQ and FDA, and supervised many large grants and contracts including the CERT program. He is the lead for the MDEpiNet Science and Infrastructure Center and patient-centered comparative research team at WCM. Co-investigator Dr. Andrew Meltzer, Assistant Professor of Surgery and of Surgery in Public Health at WCM, is an experienced researcher in surgical outcomes and comparative effectiveness vascular surgery.
MDEpiNet Public Private Partnership is a voluntary organization within the FDA’s Center for Devices and Radiological Health (CDRH) which is working to build a national medical device evaluation system bybringing together leadership, expertise, and resources to build and operate a national device ecosystem supporting the development, regulation, and use of innovative medical devices. The MDEpiNet initiative was launched under the leadership of Dr. Danica Marinac-Dabic, who serves as the Director of the Division of Epidemiology within the CDRH. Dr. Marinac-Dabic has years of experience in medical device regulatory science, particularly in the area of safety and effectiveness in the post-market setting.
The NYC-CDRN (administered from WCMC) was founded with initial support from the Patient-Centered Outcomes Research Institute (PCORI) to join its “PCORnet” program. Its mission is to create an accessible, sustainable, scalable clinical data network to facilitate patient-centered research; learning healthcare systems; and a national research network. The NYC-CDRN has developed an innovative, flexible technical architecture that (a) permits aggregation and de-duplication of patient data centrally from multiple data sources, including health systems and payers (b) preserves patient privacy and data security; and (c) make analysis-ready data available to end users in multiple data models.
Kaiser Permanente (future collaborator)
Kaiser Permanente is a partner within the MDEpiNet Science & Infrastructure Center, and boasts several inter-regional implant registries that capture patient demographics, implant characteristics, surgical techniques, and outcomes, including robust data on cardiovascular (i.e., vascular, Implantable Cardioverter Defibrillator (ICD), pacemaker, and heart valve) devices. The device registries were developed to address recall situations, disseminate best practices, identify patients at risk for failure and assess clinical effectiveness of total joint replacement implants. In addition to the inter-regional implant registries, KP also has the world’s largest private sector EHRs, KP HealthConnect®. Interconnection of all patient encounters within the EHR allows extraction of laboratory, procedural, diagnostic, pharmacy, and hospital encounters for all members in every patient care setting across KP’s regions. These data supplement inter-regional implant registries and provide a foundation for longitudinal assessment of medical devices.
The VISION Team has engaged major aortic endovascular graft manufacturers, the FDA, and the Society of Vascular Surgery Patient Safety Organization on a new project. This project will test a novel approach to evaluate patient-level data from industry pre-market device trials, Medicare claims, and the Vascular Quality Initiative registry. Entitled, “Evaluating Devices Using Claims and Registry Data” (EDUCAtE), our work will evaluate the accuracy of registry-linked claims data for use in total product life cycle surveillance of Endovascular Abdominal Aortic Aneurysm Repair devices for regulatory and scientific purposes. This study could provide the basis for a broader project to complement medical device reporting (MDR) and enhance understanding of EVAR devices in real world use. The data validation will be accomplished by comparing measured procedural and outcome data for EVAR procedures in registry and claims to the gold standard industry data submitted to the FDA. Our Industry partners include Cook Medical, Endologix, Gore Medtronics, and Bolton Medical. This work will ultimately help payers, regulators, physicians, and patients better understand how to bring innovative devices for abdominal aortic aneurysm repair to market efficiently and safely, in ways that ensure durable repair of their aneurysm.
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